analgesics - virginia medicaid pharmacy services...virginia medicaid preferred drug list, effective...

Virginia Medicaid Preferred Drug List, Effective May 11, 2011

New generic, brand, or dose formulation anticipated, will be non-preferred pending review

Last up-dated 05/16/2011 1

ANALGESICS

COX-2 Inhibitors Clinical edit

LENGTH OF AUTHORIZATIONS: 1 year

1) The preferred product may be approved for patients if one of the following is true:

a) If there has been a therapeutic trial and failure on a minimum of two (2) different non-COX2 NSAIDs

(information on history can be determined from one of the options below)

b) Electronic look back for history of paid claims for (2) different non-COX2 within the past year

c) Or a call from Physician office with history of trial and failure of two (2) different non-COX2

d) Concurrent use of anticoagulants (warfarin or heparin)

e) Chronic use of oral corticosteroids

f) Concurrent use of methotrexate

g) History of previous GI bleed or conditions associated with GI toxicity risk factors (i.e., PUD, GERD, etc.)

h) If there is a specific indication for medication requiring service authorization (SA), for which medications

not requiring service approval are not indicated, then document details and refer caller to a clinical

pharmacist

i) Patients with a diagnosis of familial adenomatous polyposis (FAP) presenting with a prescription for

celecoxib (Celebrex®) may be approved without any risk factors or trials on NSAIDs.

CRITICAL INFORMATION TO CONSIDER

1) Selective cyclooxygenase-2 (COX-2) inhibitors are known to inhibit the production of vascular prostacyclin

(PGI2), an inhibitor of platelet aggregation and a vasodilator. Unlike conventional non-steroidal anti-

inflammatory drugs, COX-2 inhibitors do not reduce the endogenous production of thromboxane A2, a potent

platelet activator and aggregator, thereby causing a potentially prothrombotic cascade of events that could lead

to a significant increase in the risk for thrombotic cardiovascular events (myocardial infarction, occlusive

stroke) in patients receiving celecoxib therapy. Therefore, it is advisable to exercise caution when prescribing

celecoxib, a COX-II inhibitors to patients with a higher risk of cardiovascular disease.

2) If the patient is allergic to one NSAID or aspirin, the patient may be allergic to other NSAIDs.

3) If allergic to sulfonamides, a patient should not receive Celebrex®.

Cox-2 Inhibitors

Preferred Drugs – No SA Required once Clinical edit met Non-preferred Drugs - N/A

Celebrex®****

****Requires a clinical SA




NSAIDs

(Non-Steroidal Anti-inflammatory Drugs including Cox-2 Inhibitors)


For COX II clinical edit see page (1)

1) Is there any reason the patient cannot be changed to a medication not requiring service authorization?

Acceptable reasons include:

o Allergy to medications not requiring service approval

o Contraindication to or drug-to-drug interaction with medications not requiring service

approval

o History of unacceptable/toxic side effects to medications not requiring service approval

Document clinically compelling information

2) The requested medication may be approved if both of the following are true:

o If there has been a therapeutic failure to no less than a one-month trial of at least two

medication(s) within the same class not requiring service approval

o The requested medications corresponding generic (if a generic is available) has been

attempted and failed or is contraindicated.

o If there is a specific indication for a medication requiring service approval, for which

medications not requiring service approval are not indicated, then document details and refer

to a clinical pharmacist.

Additional information to consider

If the patient is allergic to one NSAID or aspirin, the patient may be allergic to other NSAIDs

See next pages for specific drug lists.




NSAIDs

(Non-Steroidal Anti-inflammatory Drugs including Cox-2

Inhibitors) (Continued page 2)

NSAIDs (Non-Steroidal Anti-inflammatory Drugs) including Cox-2 Inhibitors

Preferred Drugs - No SA Required Non-preferred Drugs - SA Required

Celebrex® Anaprox

® Relafen

®

diclofenac potassium Anaprox DS®

Tolectin DS®

diclofenac sodium Ansaid® Toradol

®

diflunisal Arthrotec®

Vimovo®

etodolac Cataflam®

Voltaren®

etodolac SR Clinoril®

Voltaren XR®

fenoprofen Daypro®

Zipsor®

flurbiprofen Dolobid®

ibuprofen Feldene®

indomethacin Indocin®

indomethacin SR Indocin SR®

ketoprofen Lodine®

ketoprofen ER Lodine XL®

ketorolac mefenamic

meclofenamate sodium Mobic®

meloxicam Motrin®

nabumetone Nalfon®

naproxen Naprelan®

naproxen sodium Naprosyn®

oxaprozin Orudis®

piroxicam Oruvail®

sulindac Ponstel®

tolmetin sodium Prevacid Naprapac®




Long Acting Narcotics – Step Therapy

SHORT ACTING NARCOTICS (no SA required for generic and select preferred brands)

acetaminophen-butalbital hydrocodone w/ASA oxycodone

acetaminophen w/ codeine hydrocodone w/ Ibuprofen oxycodone w/APAP

Bupap® hydromorphone oxycodone w/ASA

buprenorphine SL levorphanol tartrate oxycodone w/Ibuprofen

butorphanol tartrate meperidine pentazocine-Naloxone

Cephadyn® morphine sulfate IR tramadol

codeine sulfate nalbuphine tramadol w/ APAP

codeine w/APAP-Caffeine opium Sedapap®

codeine w/APAP

Step-Therapy

Has the patient been tried on

two

Short-Acting Narcotics?

YES

If patient has failed on two different short-acting

narcotics or if there is any reason*****the patient

cannot be changed to a medication not requiring

service approval, PA will be granted for long-

acting narcotic

Patient must try short-acting narcotics first,

unless diagnosis requires long acting as first

line. See below*****

NO

Long-Acting Narcotics-SA Required Not for immediate postoperative pain or prn

use.

“Preferred”

(Subject to clinical edit)

Duragesic®

Kadian®

morphine sulfate Tablet SA®

“Non Preferred” Avinza

®

Embeda®

Exalgo®

**

fentanyl

MS Contin®

oxycodone-long acting*•*

Oxycontin®*•*

Opana® ER

Oramorph SR®




Long Acting Narcotics – Step Therapy

(Continued)

*****Step-Therapy is not required for those patients that have been stabilized on Long Acting

Narcotics or need relief of moderate to severe pain requiring around-the-clock opioid therapy, for an

extended period of time. Additional acceptable reasons include:

Allergy to medications not requiring service approvals

Contraindications to or drug-to-drug interaction with medications not requiring service approval

If the patient has a diagnosis that is an approved indication for the medication that requires service approval and

this diagnosis is not an indication for the medications that do not require service approval.

History of unacceptable/toxic side effects to medications not requiring service approval


LENGTH OF AUTHORIZATIONS: 6 months

OxyContin*•* / Oxycodone-long acting*•*Guidelines

1. Coverage is limited to those persons 18 years of age or older with a need for a continuous around-the-clock

analgesic for an extended period of time for the management of moderate to severe pain.

2. A fax form with diagnosis should accompany each request.

3. The main objective is to verify appropriate use and the following items should be taken into consideration when

reviewing an OxyContin request:

o Dosing frequency greater than bid (tid for an identified, organized pain clinic or pain specialist)

o Dosing using multiple small strength tablets as opposed to a single higher strength tablets

o Odd quantities that would result in fractional dosing

o Patient history of substance abuse

o Frequent early refill attempts

o Multiple request pertaining to lost medication

o Short-term or prn use (OxyContin is not indicated for short-term or prn use)

o Any suspicious use reported by pharmacies or physicians

o A rapid increase in dosage

o 80mg tablets are for opioid tolerant patients only

3. Reasons for denial:

o Split tablets

o Greater than tid dosing frequency

o Concurrent use of other extended release opioids

o Prn dosing

o Missing diagnosis on fax form

1997 Medical Society of Virginia and House of Delegates guidelines Virginia code 54.1-2971.01 states:

"In the case of a patient with intractable pain, the attending physician may prescribe a dosage in excess of the

recommended dosage of a pain relieving agent if he certifies the medical necessity for such excess dosage in the

patient's medical record. Any person who prescribes, dispenses or administers an excess dosage in accordance with

this section shall not be deemed to be in violation of the provisions of this title because of such excess dosage, if

such excess dosage is prescribed, dispensed or administered in good faith for accepted medicinal or therapeutic

purposes. Nothing in this section shall be construed to grant any person immunity from investigation or disciplinary

action based on the prescription, dispensing or administration of an excess dosage in violation of this section."




Short Acting Narcotics LENGTH OF SERVICE AUTHORIZATIONS: 3 months

1. Is there any reason the patient cannot be changed to a medication not requiring service authorization within the

same class?


Allergy to medications not requiring service approval

Contraindication to or drug-to-drug interaction with medications not requiring service approval



2. The requested medication may be approved if both of the following are true:

If there has been a therapeutic failure of no less than a one-month trial of at least one medication

within the same class not requiring service approval

The requested medications corresponding generic (if a generic is available and covered by the State)

has been attempted and failed or is contraindicated

****Clinical SA for narcotic lozenges

(Fentanyl citrate, Actiq, Fentora, and Onsolis); both of the following need to be true:

The patient has a diagnosis of cancer

The patient is already receiving and tolerant of opioid therapy for their underlying persistent cancer

pain. Patients considered opioid tolerant are those who are taking transdermal fentanyl 25 mcg/h,

morphine 60 mg/day or more, oxycodone 30 mg/day, oral hydromorphone 8 mg/day, or an

equianalgesic dose of another opioid for one week or longer.

ADDITIONAL INFORMATION TO AID IN FINAL DECISION

If there is a specific indication for a medication requiring service approval, for which medications not requiring

service approval are not indicated, then may approve the requested medication. Document the details. This

medication should be reviewed for need at each request for reauthorization.

Narcotic Lozenges

Preferred Drugs - No SA Required once Clinical edit met Non-preferred Drugs - SA Required

fentanyl citrate**** Actiq®****

Fentora®****

Onsolis®****

****Requires a clinical SA (see above criteria)

Short-Acting Narcotics

Preferred Drugs – No SA Required Non-preferred Drugs - SA Required

Generic only class All Brands require a SA

See next page for more




Short Acting Narcotics

(Continued)

Barbiturate Analgesics & Non-Salicylates Analgesic Combinations


acetaminophen-butalbital Phrenilin Forte®

Bupap® Sedapap

®

Cephadyn®

Opioid Dependency


buprenorphine SL Subutex®

Suboxone®

Suboxone®

Film




Topical Agents and Anesthetics






approval




o If there has been a therapeutic failure to no less than a one-month trial of at least one

medication within the same class not requiring service approval

o The requested medications corresponding generic (if a generic is available) has been

attempted and failed or is contraindicated.

o If there is a specific indication for a medication requiring service approval, for which

medications not requiring service approval are not indicated, then document details and refer

to a clinical pharmacist.

****Clinical Criteria for Flector®, Voltaren gel

®, and Pennsaid

®:

Approval is based on patient failing the Oral generic of the desired product and at least one other preferred NSAIDs

(to equal a total of at least two preferred).

For example, a patient who failed ibuprofen or naproxen will still need to try oral generic diclofenac for approval of

Flector.

For Pennsaid topical solution, must also be requested for an FDA approved indication. The only approvable

diagnosis is osteoarthritis of the knee.

****Clinical Criteria for Lidoderm®

Patch:

Lidoderm®

- patches can be approved for relief of pain associated with post-herpetic neuralgia.

Topical Agents and Anesthetics

Preferred Drugs - No SA Required once Clinical edit met Non-preferred Drugs - SA Required

Flector®

Patch**** Lidoderm® Patch****

Voltaren® Gel**** Pennsaid

®**** Topical Solution

**** Clinical Criteria




Tramadol Agents

LENGTH OF SERVICE AUTHORIZATIONS: 3 months

1. Is there any reason the patient cannot be changed to a medication not requiring service authorization within the

same class?















Tramadol Agents


tramadol HCL RyzoltTM

tramadol HCL/APAP tramadol ER

Ultracet®

Ultram®

Ultram ER®




Antibiotics-Anti-Infectives

Oral Antifungals for Onychomycosis

LENGTH OF AUTHORIZATIONS: For the duration of the prescription (up to 6 months)




o Contraindication to or drug-to-drug interaction with medications not requiring service approval.



2) If the patient has a serious illness that causes them to be immunocompromised (i.e. AIDS, cancer, etc.) then

may approve the requested medication.

ADDITIONAL INFORMATION TO AID IN THE FINAL DECISION

1) If the patient is completing a course of therapy with a medication requiring service approval, which was

initiated in the hospital or other similar location, or if the patient has just become Medicaid eligible and is

already on a course of treatment with a medication requiring service approval, then may approve the requested

medication.

2) If the request is for a diagnosis other than fungal infection, please refer to a clinical pharmacist.

Sporanox

If Sporanox is requested for any other FDA approved indication (other than onychomycosis), then approve for 6

months or the duration of the prescription.

Indications: Aspergillosis, Candidiasis (oral or esophageal), Histoplasmosis, Blastomycosis, empiric treatment of

febrile neutropenia

PA for Lamisil ® granules may be granted if

o Recipient is over 4 years of age

o Diagnosis is tinea capitis

Lamisil® oral granules are FDA approved for the treatment of tinea capitis (also called ringworm of the scalp) in

patients 4 years of age and older. (Lamisil® oral tablets (250mg) are FDA approved for the treatment of tinea

unguium- onychomycosis but not tinea capitis ringworm).

Oral Antifungals used for Onychomycosis


terbinafine

Grifulvin V®

Tablets

Griseofulvin Oral ®

Suspension

Gris-Peg®

itraconazole

Sporanox Solution®

Lamisil®

Sporanox Capsules®

Lamisil ®

Granules (diagnosis tinea capitis)




Antibiotics: Oral Cephalosporins, Macrolides, Quinolones

LENGTH OF AUTHORIZATIONS: for the date of service only; no refills



o Allergy to product formulation (i.e. dyes, fillers). If an allergy to drug class, should question

medication request.

o Contraindication to or drug-to-drug interaction with medications not requiring service approval



2) If the infection is caused by an organism resistant to medications not requiring service approval, then may

approve the requested medication. Document details.

Note diagnosis and any culture and sensitivity reports

3) If there has been a therapeutic failure to no less than a three-day trial of one medication within the same not

requiring service approval, then may approve the requested medication.

Document details


1) If the patient is completing a course of therapy with a medication requiring service authorization, which was

initiated in the hospital, then may approve the requested medication to complete the course of therapy.

2) If the patient requires a service authorized medication based on a specific medical need that is not covered by

the FDA indications of the preferred medications, then allow the non-preferred medication. This information

should be reviewed at each request for reauthorization.

Second Generation Quinolones


ciprofloxacin Cipro®

Maxaquin®

ciprofloxacin Susp

Noroxin®

Cipro XR®

ofloxacin

ciprofloxacin ER

Proquin XR®

Floxin®

Cipro® Suspension

Third Generation Quinolones


Avelox®

Avelox® ABC PACK

Factive®

Proquin XR®

Levaquin®

Zagam®

Levaquin Susp ®




Drug list continues next page

Antibiotics: Oral Cephalosporins, Macrolides, Quinolones (Continued page 2)

Preferred Drugs - No SA Required Non-Preferred Drugs - SA Required

Second Generation Cephalosporins

cefaclor capsule Ceftin®

tablets

cefaclor ER Ceftin®

suspension

cefaclor suspension Cefzil®

cefprozil Cefzil®

suspension

cefprozil Suspension cefuroxime axetil susp

cefuroxime tablets

Raniclor®

Third Generation Cephalosporins

cefdinir capsule Cedax Capsule® Omnicef Capsules

®

cefdinir suspension Cedax Susp® Omnicef Susp

®

Spectracef® Cefditoren pivoxil Vantin

®

Suprax® Suspension cefpodoxime proxetil Vantin Susp

®

cefpodoxime proxetil susp

Macrolides and Ketolides

azithromycin Biaxin®

azithromycin packet Biaxin Suspension®

azithromycin suspension Biaxin XL®

clarithromycin Dynabac®

clarithromycin suspension clarithromycin ER

E.E.S. ®*••* Ery-tab

®

EryC®*••* Ketek

®******

Eryped®*••* PCE

®

erythrocin stearate Zithromax Suspension®

erythromycin base Zithromax®

erythromycin ethylsuccinate ZMAX Suspension®

erythromycin estolate suspension

erythromycin stearate

erythromycin / sulfisoxazole

*••* Generics not available in some strengths/dosage forms

******To receive a PA for Ketek®, a specific Ketek PA request form must be completed and faxed or mailed to

First Health Services with the physician's signature. By signing this request, the physician accepts understanding of

the contraindications and warnings with the use of Ketek and acknowledges that the benefits of the drug outweigh

the possible risks.

o A copy of the SA form is available at http://www.virginiamedicaidpharmacyservices.com.

http://www.virginiamedicaidpharmacyservices.com/




o The SA may also be completed online at:

https://webpa.magellanhmedicaieadministration.com/webpa .

o Recipient must be 18 or over and can only be approved for an FDA indication

Otic Quinolones

LENGTH OF AUTHORIZATION: for the date of service only; no refills

1) Is there any reason the patient cannot be changed to a medication not requiring service approval within the same

class?





o Patient’s condition is clinically unstable; changing to a medication not requiring service approval

might cause deterioration of the patient’s condition.


2) If there has been a therapeutic failure of a trial of at least one medications not requiring service approval, then



1) If the patient is completing a course of therapy with a medication requiring service approval, which was

initiated in the hospital or other similar location, or if the patient has just become Medicaid eligible and is

already on a course of treatment with a medication requiring service approval, then may approve the requested

medication.

2) An indication that is unique to a non-preferred agent and is supported by peer-reviewed literature or a FDA-

approved indication, or Age specific indication, or Medical co-morbidity, unique patient circumstance, other

medical complications, or Clinically unacceptable risk with a change in therapy to preferred agent.

Otic Quinolones


Ciprodex® (ciprofloxacin/dexamethasone)

ofloxacin (generic for Floxin®) Cipro HC

® (ciprofloxacin/hydrocortisone)

Cetraxal®

Floxin®

https://webpa.magellanhmedicaieadministration.com/webpa




Topical Antibiotics:


1) Is there any reason the patient cannot be changed to a medication not requiring service approval? Acceptable

reasons include:


medication request.





approve the requested medication.

Document details and note diagnosis and any culture and sensitivity reports

3) If there has been a therapeutic failure to no less than a three-day trial of one medication within the same class

not requiring service approval, then may approve the requested medication.

Document details

Topical Antibiotics


Mupirocin Ointment Bactroban®

Cream

Bactroban®

Ointment

CentanyTM

Altabax® *•••*

*•••* Has a 15 gram per 34 day quantity limit




Antivirals

Interferon for Hepatitis C

LENGTH OF AUTHORIZATIONS: See below

Clinical SA for initial 16 week SA:

1) Initial approval periods should be limited to 16-weeks and viral titer should be obtained at week 12 of therapy.

Clinical SA for established HCV reactors:

1) Therapy is approvable for a total of 24 weeks in patients that are HCV genotypes 2 or 3 who have achieved a

virologic response (either undetectable HCV RNA [<50 IU/mL] or at least a 2-log drop in HCV RNA titer from

baseline) at 12 weeks of treatment.

2) Therapy is approvable for total of 48 weeks in HCV genotype 1 or 4 patients who have achieved a virologic

response (either undetectable HCV RNA [<50 IU/mL] or at least a 2-log drop in HCV RNA titer from baseline)

at 12 weeks of treatment.

3) If patients fail to achieve a virologic response by 12 weeks, further treatment is not indicated.

PDL SA

1) Is there any reason the patient cannot be started on a medication not requiring service approval?


o Allergy to product formulation (i.e. dyes or fillers). If an allergy to drug class, should question

medication request.




2) Has there been a therapeutic failure after a reasonable therapeutic trial with use of one of the non-service

authorized agents? Document the details, and forward all of these requests to a clinical pharmacist.

Additional Information:

1) Copegus® and Rebetol

® are oral ribavirins. Oral ribavirin therapy is not effective for the treatment of chronic

hepatitis C viral infection and should not be used alone for this indication.

2) Pegasys® and PEG-Intron

® are pegylated Interferons.

Antivirals: Interferon****


Pegasys®

Pegasys Conv.Pack®

Peg-Intron®

Peg-Intron Redipen®





Herpes



class?










Antivirals: Herpes


acyclovir Tablets

acyclovir Susp

Famvir ®

Valtrex ®

famciclovir

valacyclovir

Zovirax®

Susp

Zovirax®

Tablet




Influenza

LENGTH OF AUTHORIZATIONS: For diagnosis of influenza the authorization is for the date of service only;

no refills


class?








2) If there has been a therapeutic failure of a trial of at least one medication not requiring service approval, then


Antivirals: Influenza


amantadine

amantadine Syrup

Relenza Disk®

rimantadine

Tamiflu®

Tamiflu® Susp

Flumadine®

Flumadine®

Syrup




Antivirals Topical: Herpes



class?










Antiviral Topical: Herpes


Abreva OTC®

Zovirax®

ointment

Denavir®

Zovirax®

cream

Xerese®

cream




Cardiac

ACE Inhibitors, Angiotensin Receptor Blockers, Beta-Blockers

LENGTH OF AUTHORIZATION: 1 year


class?




approval




o If there has been a therapeutic failure of no less than a one-month trial of at least one


o The requested medications corresponding generic (if a generic is available and covered by the

State) has been attempted and failed or is contraindicated


1) If there is a specific indication for a medication requiring service approval, for which medications not requiring

service approval are not indicated, then may approve the requested medication.

2) Document details

This medication should be reviewed for need at each request for reauthorization.

ACE Inhibitors


benazepril

captopril

enalapril

lisinopril

Accupril®

Monopril®

Aceon®

perindopril

Altace Capsule®

Prinivil®

Altace Tablet®

quinapril

Capoten®

ramipril

fosinopril

trandolapril

Lotensin®

Univasc®

Mavik®

Vasotec®

moexipril




Zestril®

ACE Inhibitors, Angiotensin Receptor Blockers,

Beta-Blockers (continued page 2)

ACE Inhibitors + Diuretic Combinations


benazepril/HCTZ

captopril/HCTZ

enalapril/HCTZ

lisinopril/HCTZ

Accuretic®

Prinzide®

Capozide®

quinapril/HCTZ

fosinopril/HCTZ

Quinaretic®

Lotensin HCT®

Uniretic®

Monopril HCT®

Univasc®

moexipril/HCTZ

Vaseretic®

Zestoretic®

ACE Inhibitors + Calcium Channel Blocker Combinations


amlodipine/benazepril

(2.5/10, 5/10, 5/20 & 10/20 generic preferred)

Lotrel® (5/40 and 10/40 brand preferred)

amlodipine/benazepril (5/50 and 10/40)

Teczem®

Lexxel®

trandolapril/verapamil hydrochloride ER

Lotrel® (2.5/10, 5/10, 5/20 & 10/20)

Tarka®

Angiotensin Receptor Blockers


Diovan® *

losartan

Atacand®

Cozaar®

Avapro®

Micardis®

Benicar®

Teveten®

*Step edit requires a trial and failure of losartan




Angiotensin Receptor Blockers + Diuretic Combinations


Diovan HCT®*

losartan/HCTZ

Atacand HCT®

Hyzaar®

Avalide®

Micardis HCT®

Benicar HCT®

Teveten HCT®

*Step edit requires a trial and failure of losartan/HCTZ

Angiotensin Receptor Blockers + Calcium Channel Blocker Combinations


N/A Azor®

Exforge®HCT

Exforge®

Tribenzor®

ACE Inhibitors, Angiotensin Receptor Blockers, Beta-Blockers

(Continued page 3)

Direct Renin Inhibitors


N/A Tecturna®

Twynsta

Tecturna HCT®

Valturna®

Beta Blockers


acebutaolol

atenolol

bisoprolol fumarate

metoprolol tartrate

nadolol

pindolol

propranolol solution

propranolol

Sorine®

sotalol HCL

sotalol AF

timolol maleate

Betapace®

Levatol®

Betapace AF®

Lopressor®

betaxolol

metoprolol succinate

Blockadren®

propranolol LA

Bystolic®

Normodyne®

Cartrol®

Sectral®

Corgard®

Tenormin®

Inderal®

Toprol XL®

Inderal LA®

Visken®




Innopran XL®

Zebeta®

Kerlone®

Alpha/Beta Blockers


carvedilol

labetalol

Coreg®

Trandate®

Coreg CR®

Beta Blockers + Diuretic Combinations


atenolol/chlorthalidone

bisoprolol/HCTZ

metoprolol/HCTZ

nadolol/bendroflumethiazide

propranolol/HCTZ

Corzide®

Tenoretic®

Inderide®

Timolide®

Lopressor HCT®

Ziac®

TOPROL XL®: Authorize if any of the following are true

Toprol XL®

25mg po qd will be authorized as it would not be feasible to promote metoprolol 12.5mg po BID.

Toprol XL®

25mg will be authorized with a quantity limit of 45 tablets per 30 days.

Doses >37.5 mg Toprol XL®

po qd will be offered a change to metoprolol in a total daily dose divided by two and

dosed BID

If patient compliance is questioned or compromised by change, then the Toprol XL®

will be authorized

Calcium Channel Blockers:

Dihydropyridine Calcium Channel Blockers and

Non-dihydropyridine Calcium Channel Blockers



class and formulation?










o If there has been a therapeutic failure to no less than a one-month trial of at least one medication



state) has been attempted and failed or is contraindicated

CLINICAL NOTES

There are two main classes of Calcium Channel Blockers (each with different actions on the peripheral vasculature

and cardiac tissue):

o Dihydropyridine Calcium Channel Blockers (DHPCCB)

o Non-Dihydropyridine Calcium Channel Blockers (NDHPCCB)

See next page for specific drug lists.

Calcium Channel Blockers:

Dihydropyridine Calcium Channel Blockers and

Non-dihydropyridine Calcium Channel Blockers

(Continued page 2)

Calcium Channel Blockers





Dihydropyridine Calcium Channel Blockers

Afeditab CR®

amlodipine

Dynacirc CR®

felodipine ER

nicardipine

Nifediac CC®

Nifedical XL®

nifedipine

nifedipine ER

nifedipine SA

Adalat ®

Procardia XL®

Adalat CC®

Plendil®

Cardene®

Sular®

Cardene SR®

Dynacirc®

Dynacirc CR®

isradipine

nisoldipine

Norvasc®

Procardia®

Non-Dihydropyridine Calcium Channel Blockers

Cartia XT®

Diltia XT®

diltiazem

diltiazem ER q 24hr dose

diltiazem ER q 12hr dose

diltiazem XR

Taztia XT®

verapamil

verapamil SA

verapamil 24hr pellets

Calan®

Dilacor XR®

Calan SR®

diltiazem SR q 12hr dose

Cardizem®

Isoptin SR®

Cardizem CD®

Tiazac®

Cardizem LA®

Verelan®

Cardizem SR®

Verelan PM®

Covera HS®

Lipotropics


General Guidelines:




Currently there are four classes of medications in the Lipotropics represented on the PDL. Each class has a different

mechanism of action and acts on different components of total cholesterol

Fibric acid derivatives-& Omega 3 agent

HMG COA reductase Inhibitors

Nicotinic acid derivatives

Bile Acid Sequestrants


class?








2) If there have been therapeutic failures to no less than three-month trials of at least one medication not requiring

service approval, then may approve the requested medication.

Document details

Omacor®/Lovaza®

o Step edit is the trial and failure of any other lipotropic.

o A SA may also be approved without any specific preferred medication trial, if they have

documented very high triglycerides of (≥ 500 mg/dL) in adult patients.

Lipotropics – HMG CoA Reductase Inhibitors and Combinations (Statins)


lovastatin

pravastatin

Advicor®

Lescol XL®

Altoprev®

Mevacor®

Lescol®

Pravachol®

Lipotropics – HMG CoA Reductase Inhibitors and Combinations (High Potency Statins)


simvastatin Crestor®

Vytorin®

Lipitor®

Zocor®

Livalo®

See next pages for more drug lists.

Lipotropics (Continued page 2)

Lipotropics – Fibric Acid Derivatives





Antara®

gemfibrozil

fenofibrate

Lopid®

Fenoglide®

Triglide®

Lipofen®

Tricor®

Lofiibra®

Trilipix™

Lipotropics – Niacin Derivatives


Niacor®

Niaspan®

Lipotropics – Niacin Derivatives & HMG CoA Reductase Inhibitors (Statins) Combination


Simcor®**

** Requires a history of either a niacin or Simvastatin product within the past 356 days.

Lipotropics - CAI


Zetia®

Lipotropics – Omega 3 Fatty Acid agent

Preferred Drugs - No SA Required Non-preferred Drugs – SA Required

*Lovaza®

*Step edit requires a trial and failure of any one other Lipotropic

Lipotropics – Bile Acid Sequestrants

Preferred Drugs - No SA Required Non-preferred Drugs – SA Required

Cholestyramine

Cholestyramine Light

Colestid® Granules

Colestid®Packet

Colestid® Tablet

Colestipol HCl Granules

Colestipol HCl Packet

Colestipol HCl Tablet

Prevalite®

Questran Light ®

Questran® Tablet

Welchol®

Welchol Packets®

LOW MOLECULAR WEIGHT HEPARINS




INCLUDES SELECTIVE FACTOR XA INHIBITOR

(FONDAPARINUX)



class?







o If there has been a therapeutic failure of no less than a one-month trial of at least one medication




Low Molecular Weight Heparin


Arixtra ® enoxaparin

Fragmin ® Innohep

®

Lovenox ®




Phosphodiesterase 5 Inhibitors

Pulmonary Arterial Hypertension


1) Diagnosis of Pulmonary Hypertension in patients 18 years of age or older is required.


o The prescribing physician is a pulmonary specialist or cardiologist.

o Client has documented Pulmonary Arterial Hypertension and will be followed by the prescribing physician.

o Recipient must have a rationale for not taking the oral Revatio to receive a SA for the injectable Revatio.

Document clinically supporting information

Contraindications where the SA should not be approved:

o Concurrent use of nitrates (e.g., nitroglycerin)

o Hypersensitivity to productl

PDE5 Inhibitor


Adcirca TM

Revatio®

Revatio injection®




Platelet Inhibitors



class?


o Allergy to at least two unrelated medications not requiring service approval





o If there has been a therapeutic failure of no less than a three-month trial of at least one medication




Platelet Inhibitors


Aggrenox®

dipyridamole

Plavix®

ticlopidine HCL

Effient®****

Persantine®

****Clinical criteria

****Clinical Criteria for Effient®:

For new patients, does the patient have a diagnosis of acute coronary syndrome (ACS) and the indication is for

reduction of thrombotic cardiovascular events (including stent thrombosis).

The patient must not have active pathological bleeding or history of transient ischemic attack (TIA) or stroke.

The patient must be currently managed with Percutaneous Coronary Intervention (PCI).




Central Nervous System

Non-Ergot Dopamine Receptor Agonist



class?











o If requested for treatment of Parkinson’s, may approve without the necessary trial of a preferred

agent if the patient has swallowing issues that causes them to be unable to use a preferred product

OR if the request is for continuation of established therapy.

o If requested for treatment of restless legs, forward request to a pharmacist to be denied.

o An indication that is unique to a non-preferred agent and is supported by peer-reviewed literature

or an FDA-approved indication, or Age specific indication, or Medical co-morbidity, unique

patient circumstance, other medical complications, or Clinically unacceptable risk with a change

in therapy to preferred agent.

Non-Ergot Dopamine Receptor Agonists


pramipexole

ropinirole HCl

Mirapex®

Mirapex ER®

Requip®

Requip Dose Pack®

Requip®

XR




Sedative/ Hypnotics

LENGTH OF AUTHORIZATIONS: Length of the prescription (up to 3 months)


class?






2) To receive a non preferred benzodiazepine there must have been a therapeutic failure to no less than a one-

month trial of at least one benzodiazepine not requiring service approval, then may approve the requested

medication.

Document details

3) To receive a preferred non benzodiazepine there must have been a therapeutic failure to no less than a one-

month trial of a benzodiazepine (step edit)

4) To receive a non preferred non benzodiazepine there must have been a therapeutic failure to no less than a

one-month trial of

o First a benzodiazepine (step edit)

o Second a therapeutic failure to not less than a one-month trial of Rozerem®

Then may approve the requested medication

Document details

5) For patients age 65 and older, Rozerem®, Ambien® or Lunesta may be approved after a trial of trazodone

(duration = at least one month). It is not necessary for patient’s ≥ 65 to try a benzodiazepine if they have had a

trial of trazodone.

Sedative Hypnotics (Benzodiazepine)


estazolam

flurazepam

temazepam

triazolam

chloral hydrate Syrup

Dalmane®

Doral®

Halcion®

Prosom®

Restoril®

Sedative Hypnotics (Non-Benzodiazepine) See step edit


Rozerem® * Ambien

®

Somnote®

Ambien CR®

Sonata®

EdluarTM

Zaleplon®

Lunesta®

zolpidem

* Must meet Step edit as noted above to receive Rozerem




Serotonin Receptor Agonists “Triptans”

LENGTH OF AUTHORIZATIONS: 6 months

1) Is there any reason the patient cannot be switched to a non-service approved medication?


o Allergy to one of the non-service approved products

o Contraindication to all non-service approved product(s)

o History of unacceptable side effects to one of the non-service approved product(s)


2) Has the patient had therapeutic trial of one non-service authorized drug that failed? If so, document and allow

the service authorized medication.

CLINICAL CONSIDERATIONS:

Service Authorization will not be given for prophylactic therapy of migraine headache unless the patient has

exhausted or has contraindications to all other ―controller‖ migraine medications (i.e., beta-blockers, calcium

channel blockers, etc) and the physician and patient are aware of the adverse risk potential.

Triptans


Maxalt ® MLT

Relpax®

Sumatriptan Succinate Cartridge

Sumatriptan Succinate Nasal

Sumatriptan Succinate Pen

Sumatriptan Succinate Tablets

Sumatriptan Succinate Vial

Amerge®

naratriptan

Axert®

Cambia®

Treximet

Frova®

Zomig Tablets®

Imitrex® Cartridge

Zomig nasal spray ®

Imitrex® Nasal

Zomig ZMT®

Imitrex® Pen Kit

Imitrex® Tablets

Imitrex ® Vial

Maxalt®




Skeletal Muscle Relaxants

LENGTH OF SERVICE AUTHORIZATIONS: 1 year for chronic conditions

Duration of prescription (up to 3 months) for acute conditions

1. Is there any reason the patient cannot be changed to a medication not requiring service approval within the same

class?







1. If there has been a therapeutic failure of no less than a one-month trial of at least one medication


2. The requested medications corresponding generic (if a generic is available and covered by the State)



1. If there is a specific indication for a medication requiring service approval, for which medications not

requiring service approval are not indicated, then may approve the requested medication. Document

the details. This medication should be reviewed for need at each request for reauthorization.

2. Chronic Conditions:

Multiple Sclerosis

Spasticity

Cerebral Palsy

Muscle rigidity as a result of spinal cord/ brain injury or disease

3. Acute Conditions:

Muscle spasm associated with acute painful musculoskeletal conditions (ex. Generalized back, neck, or shoulder

pain and muscle spasms attributed to trauma

Skeletal Muscle Relaxants


baclofen

carisoprodol

carisoprodol/ASA

carisoprodol/ASA/codeine

chlorzoxazone

cyclobenzaprine HCL

dantrolene sodium

methocarbamol

orphenadrine citrate

orphenadrine/ASA/caffeine

tizanidine

Amrix®

Dantrium®

Fexmid®

Flexeril®

metaxalone

Norflex®

Parafon Forte DSC®

Robaxin®

Skelaxin®

Soma®

Zanaflex®




Smoking Cessation


Step edit for Chantix

The patient must have a therapeutic failure of no less than a one-month trial of at least one medication

within the OTC class not requiring service approval.


class?











Smoking Cessation Agents


bupropion SR Chantix®*

nicotine gum Chantix®

Tab DS PK*

nicotine lozenge Commit ®

Lozenge

nicotine patch Nicoderm CQ®

Patch

Nicotrol®

Nicotrol ®

NS

Zyban®

* Requires a step edit




Stimulants/ADHD Medications

Length of Authorization: 1 year

1) Is there any reason the patient cannot be changed to a medication not requiring service approval?






2) If there has been a therapeutic failure to no less than a one-month trial of at least one medication not requiring


Document details

3) The patient must have failed the generic product (if covered by the State) before the brand is authorized.

4) If the patient requires a service authorized medication based on a specific medical need that is not covered by

the FDA indications of the preferred medications, then allow the non-preferred medication. This should be

reviewed for need at each request for reauthorization.

ADHD Amphetamine Products


amphetamine Salts combo

dextroamphetamine

Vyvanse®

Adderall®

Dextrostat®

Adderall XR®

methamphetamine

amphetamine Salts combo XR

Desoxyn®

Dexedrine®

dextroamphetamine SR

ADHD Methylphenidate Products


Concerta®

Focalin XR®

All methylphenidate Generic IR

Daytrana™ Transdermal

Methylin solution®

dexmethylphenidate

methylphenidate oral solution

Focalin®

methylphenidate SR

Metadate CD®

Procentra solution®

Metadate ER®

Ritalin®

Ritalin LA®

Methylin chew®

Ritalin SR®

Methylin ER®

ADHD Miscellaneous Products





Strattera® Nuvigil

TM

Provigil®

Dermatologic

Dermatologic Agents



class?








2) Has there been a failure to respond to a therapeutic trial of at least two weeks of one preferred medication? If

yes, allow the service authorized medication. Document details.


o Topical retinoids will reject for 21 and older - this can not be over ridden.

o Renova and other products considered to have only a cosmetic indication are not covered by

Virginia Medicaid.

o If the patient is completing a course of therapy with a medication requiring service approval,

which was initiated in the hospital or other similar location, or if the patient has just become

Medicaid eligible and is already on a course of treatment with a medication requiring service

approval, then the requested medication may be approve.

Combo benzoyl peroxide & Clindamycin


benzoyl peroxide Benzaclin® Duac CS

®

clindamycin Benzaclin ®

CareKit Duac®

gel

Clindamycin 1%/Benzoyl Peroxide 5%

Topical Retinoids/Combinations


Differin® cream 0.1% adapalene 0.1%

cream

Epiduo®

Differin®

gel 0.1% & 0.3% adapalene 0.1%

topical gel

Retin-®

A

Retin®-A Micro Altinac

® Tazorac

®

Retin®-A Micro Pump atralin Tretin

®-X

Tretinoin Differin®

0.1%

topical lotion

Ziana®




Topical Agents for Psoriasis


calcipotriene Anthralin Taclonex®

Dovonex® Dovonex

® Scalp Taclonex

® Scalp

Psoriatic® Micanol

® Vectical

®

Endocrine and Metabolic agents

Androgenic Agents (Testosterone – Topical)

Length of authorization: 1 year

1. Is there any reason the patient cannot be changed to a medication not requiring service approval?






2. Has there been a failure to respond to a therapeutic trial of at least one week of one non-service authorized

medication? If yes, allow the service authorized medication.

Document details

Androgenic Agents


Androderm

Androgel

Testim




Contraceptives

LENGTH OF SERVICE AUTHORIZATIONS: 1 year


class?






2. The requested medication may be approved if the following is true:


has been attempted and showed unacceptable/toxic side effects or there is an allergy, contraindication,

or drug-to-drug interaction.





All Oral Contraceptives


Generic only class with one exception All brands except YAZ require a SA

YAZ

Etonogestrel/Ethinyl Estradiol Vaginal Ring


NuvaRing®

Norelgestromin/Ethinyl Estradiol Transdermal


Ortho Evra®




Diabetes Hypoglycemics: Injectable Amylin Analogs


Clinical step edit for Symlin® (pramlntide)

The recipient must have a history of at least a 90 day trial of insulin.

Symlin is only indicated as adjunct therapy with insulin. If the claim rejects, and the patient is not using

any type of insulin, forward request to a pharmacist

Recipient meeting ALL of the following criteria may be approved:

Diagnosis of Type 1 or 2 diabetes

On insulin therapy

Failure to achieve adequate glycemic control (HbA1c ≤ 6.5%)




Diabetes Hypoglycemics: Injectable Incretin Mimetics

LENGTH OF SERVICE AUTHORIZATIONS: 1 year


class?















Injectable Incretin Mimetics


Byetta® Victoza

®




Diabetes Hypoglycemics: Injectable Insulins




Allergy to the non-service approved products in this class

Contraindication or drug to drug interaction with all non-service approved products

History of unacceptable side effects


2) Therapeutic failure of one non-service authorized medication. For approval of a non-preferred insulin,

the patient must have a failure on the equivalent preferred product if one is available (ex. Approval of

Humalog® would require a failure on Novolog®).

3) Pens/cartridges should only be approved if there is a physical reason (such as dexterity problems,

vision impairment) vials cannot be used. Approvals should not be granted based on issues of

convenience or compliance. Will be approved for individuals meeting the following criteria: Recipient or caregiver has poor eyesight such that dosing errors may occur

Recipient or caregiver has problems with manual dexterity which may result in dosing errors (i.e.

Parkinson’s disease, rheumatoid arthritis in the finger/hand joints, multiple sclerosis)

Recipient is under 18 years of age

Additional information to aid in the final decision: If Humalog® is authorized and the patient is to mix with Humulin® (any formulation), then approve the

Humulin® medication(s).

Long-Acting Insulins


Levemir Vial Lantus Solostar

Lantus Vial Lantus Cartridge

Levemir Pen

Rapid-Acting Insulins


Humalog® Vial Apidra Solostar Humalog® Cartridge Apidra Cartridge

Humalog® Pen - not available Apidra Vial Humalog® Kwikpen Novolog® Vial Novolog® Cartridge

Novolog® Flexpen Syringe




Continued on next page

Diabetes Hypoglycemics: Injectable Insulins

(Continued page 2)

Insulin Mix


Humalog Mix 75/25 Vial

Humalog Mix 50/50 Vial

Humalog Mix 50-50 Kwikpen

Humalog Mix 75-25 Kwikpen

Novolog Mix 70/30 Vial

Novolog Mix 70/30 Pen

Humalog Mix 75/25 Pen - not available

Humalog Mix 50/50 Pen - not available

Insulin 70/30


Humulin 70/30 Vial

Humulin 70/30 Pen

Novolin 70/30 Vial

Novolin 70/30 Pen - not available

Novolin 70/30 Cartridge not available

Insulin N


Humulin N Vial

Humulin N Pen

Novolin N Vial

Novolin N Pen - not available

Insulin R


Humulin R Vial

Novolin R Vial

Humulin N Pen- not available




Diabetes Oral Hypoglycemics

LENGTH OF AUTHORIZATIONS: 1 Year



o Allergy to the non-service approved products in this class

o Contraindication or drug to drug interaction with all non-service approved products

o History of unacceptable side effects


5) Has the patient tried and failed a therapeutic trial of thirty days with one of the non-preferred drugs within the

same class? If so, document and approve the service authorized drug.

Oral Hypoglycemics Alpha-Glucosidase Inhibitors


acarbose Precose®

Glyset®

Oral Hypoglycemics Biguanides


metformin Fortamet® Glutmetza

®

metformin ER Glucophage®

Riomet®

suspension

Glucophage ®

XR

Oral Hypoglycemics Biguanide Combination Products


Avandamet® Glucovance

®

glipizide/metformin Metaglip®

glyburide/metformin

Oral Hypoglycemics DPP-IV inhibitors and combination


Januvia®

Janumet®

OnglyzaTM

Oral Hypoglycemics Meglitinides


Starlix® Nateglinide PrandiMet

TM

Prandin®




Continued on next page

Diabetes Oral Hypoglycemics

(Continued page 2)

Oral Hypoglycemics Thiazolidinediones


Actos 15mg® Actos 30mg

® and Actos 45mg

®

Avandamet® Actoplus Met

®

Avandia® Avandaryl

®

Duetact®

Oral Hypoglycemics Second Generation Sulfonylureas


glimepiride Amaryl®

glipizide Diabeta®

glipizide ER Glucotrol®

glyburide Glucotrol XL®

glyburide micronized Glynase®

Micronase®




Gout Suppressants (Antihyperuricemics)



class?


o Allergy to medication not requiring service approval

o Contraindication to or drug-to-drug interaction with medication not requiring service approval

o History of unacceptable/toxic side effects to medication not requiring service approval


2) Has the patient tried and failed a therapeutic trial with a preferred drug within the same class? If so, document

and approve the service authorized drug.

Clinical Criteria For: Colcrys™

Colcrys™ will be approved if any one of the following is true:

Diagnosis of Familial Mediterranean Fever; OR

For Acute Gout Flare:

o Trial and failure of one of the following:

NSAID (i.e., indomethacin, naproxen, ibuprofen, sulindac, ketoprofen)

Corticosteroid; OR

References

1. Facts and Comparisons on-line. Version 4.0; Wolters Kluwer Health, Inc.; 2010. Accessed September 14, 2010. 2. Thompson MICROMEDEX on-line © 1974-2010. Accessed September 14, 2010.

3. Provider Synergies. Antihyperuricemics Review. May 6, 2010.

Gout Suppressants


allopurinol Uloric®

colchicine Colcrys®

Probenecid®

Probenecid and Colchicine




Growth Hormone Pediatrics

LENGTH OF AUTHORIZATION (pediatrics): 1 year

PEDIATRICS (18 years of age and under) Clinical Criteria for Approval:

1) Prescriber is an endocrinologist, nephrologists, infectious disease specialist or HIV specialist or one has been

consulted on this case,.

2) The patient has open epiphysis and one of the following diagnoses

o Turner Syndrome

o Prader-Willi Syndrome

o Renal insufficiency

o Small for gestational age (SGA) - including Russell-Silver variant and patient is < 2 years old

o Idiopathic Short Stature (for request for renewal only (a) information is required to be approved)

o Growth hormone deficiency (physician should provide the required information below)

o Newborn with hypoglycemia and a diagnosis of hypopituitarism or panhypopituitarism.

3) Height is more than 2 SD (standard deviations) below average for the population mean height for age and sex,

and a height velocity measured over one year to be 1 SD below the mean for chronological age, or for children

over two years of age, a decrease in height SD of more than 0.5 over one year; AND

4) Growth hormone response of less than 10ng/ml to at least two provocative stimuli of growth hormone release:

insulin, levodopa, L-Arginine, clonidine, or glucagon

Requests for Renewal (pediatrics):

1) For renewal, a response must be documented. Patient must demonstrate improved/normalized growth velocity.

(Growth velocity has increased by at least 2 cm in the first year and is greater than 2.5 cm per year), AND

2) Patient height is less than 5’ 6" for males or 5' 1" for females, and is more than 1 standard deviation (2") below

mid-parental height (unless parental height is diminished due to medical or nutritional reasons).

PDL CRITERIA


class?







authorized agents? Document the details, and forward all of these requests to a clinical pharmacist

See Growth Hormone for all groups for list of preferred/non-preferred




Growth Hormone Adults

LENGTH OF AUTHORIZATION: 1 year (Serostim® – 3 months *** see below)

ADULTS (> 18 years of age) Clinical Criteria for Approval:

1. Prescriber is an endocrinologist

2. Diagnosis of growth hormone deficiency confirmed by growth hormone stimulation tests and rule-out of

other hormonal deficiency, as follows: growth hormone response of fewer than five nanograms per mL to

at least two provocative stimuli of growth hormone release: insulin, levodopa, L-Arginine, clonidine or

glucagon when measured by polyclonal antibody (RIA) or fewer than 2.5 nanograms per mL when

measured by monoclonal antibody (IRMA);

3. Cause of growth hormone deficiency is Adult Onset Growth Hormone Deficiency (AO-GHD), alone or

with multiple hormone deficiencies, such as hypopituitarism, as a result of hypothalamic or pituitary

disease, radiation therapy, surgery or trauma

4. Other hormonal deficiencies (thyroid, cortisol or sex steroids) have been ruled out or stimulation testing

would not produce a clinical response such as in a diagnosis of panhypopituitarism.

Zorbtive®

o Diagnosis of short bowel syndrome

Serostim®

o Diagnosis of AIDS Wasting or cachexia

o Patient has a documented failure, intolerance, or contraindication to appetite stimulants and/or other

anabolic agents (both Megace® and Marinol®)

***Length of Authorization (Serostim® only): 3 months initial; then 1 year.

Renewal is contingent upon improvement in lean body mass or weight measurements.

Requests for Renewal (adults)

Renewal is contingent upon prescriber affirmation of positive response to therapy (improved body composition,

reduced body fat, and increased lean body mass).

PDL CRITERIA


class?







authorized agents?

Document the details, and forward all of these requests to a clinical pharmacist.




Growth Hormone Adults & Pediatrics continued pg 3

Growth Hormones for all groups


Genotropin®**** Humatrope

® Cartridge

Nutropin AQ®

NuSpinTM

**** Humatrope Vial®

Norditropin Cartridge®

Norditropin FlexPro®

Norditropin Nordiflex®

Nutropin®****

Nutropin AQ® Cartridge****

Nutropin AQ® Vial****

Omnitrope®

Saizen Vial®

Saizen Cartridge®

Serostim®

Tev-Tropin®

Zorbtive®

**** Requires a clinical SA




Erythropoiesis Stimulating Proteins:

Epogen®, Procrit® (Erythropoietin)

& Aranesp® (Darbepoetin)

LENGTH OF AUTHORIZATION: for duration of the prescription up to 6 months


class?











Clinical Information for Pharmacists;

RENEWAL REQUESTS for patients with anemia due to chronic renal failure/end stage renal disease should be

approved, even if the Hgb or Hct are above the cutoff point.

Hematopoietic Agents


Procrit® Aranesp

®

Epogen®




Progestational Agents


1. Is there any reason the patient cannot be changed to a medication not requiring service approval?






2. Has there been a failure to respond to a therapeutic trial of at least one week of one non-service authorized

medication? If yes, allow the service authorized medication.

Document details

Progestational Agents


medroxyprogesterone acetate

norethindrone acetate

progesterone

Provera®

Prometrium®




Progestins Used For Cachexia


1. Is there any reason the patient cannot be changed to a medication not requiring service approval within the

same class?











Progestins Used for Cachexia


megestrol acetate Megace®

Megace®

ES




Vaginal Estrogens



class?















Vaginal Estrogens


Premarin Vaginal Cream Estrace Vaginal Cream

Vagifem Vaginal Tablets Estring Vaginal Ring

Femring Vaginal Ring




Gastrointestinal

Histamine -2 Receptor Antagonists (H-2 RA)



class?





o Patient’s condition is clinically unstable—patient has had an ER visit or at least two

hospitalizations for asthma in the past thirty days—changing to a medication not requiring service

approval might cause deterioration of the patient’s condition.


2) If there has been a therapeutic failure to no less than a one-month trial of at least one medication not requiring


3) If a medication requiring service approval was initiated in the hospital for the treatment of a condition such as a

GI bleed, and then may approve the requested medication.

4) Treatment of warts is not an FDA approved diagnosis or indication for Tagamet / cimetadine and a SA will not

be approved for this diagnosis or indication.

Document details

H2 Receptor Antagonists


famotidine Axid®

capsule nizatidine suspension

ranitidine Axid ®

solution Pepcid oral suspension®

ranitidine syrup cimetidine syrup Pepcid ®

tablet

cimetidine tablet Tagamet®

famotidine oral

suspension

Zantac®

tablet

nizatidine Zantac® syrup




Motility Agents – GI Stimulants

LENGTH OF SERVICE AUTHORIZATIONS: 12 weeks


class?















All products are subject to a 12 week course of use. Black box warning placed on product 2/27/2009

WARNING: TARDIVE DYSKINESIA

Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The

risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose.

Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There

is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide

treatment is stopped.

Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit

is thought to outweigh the risk of developing tardive dyskinesia.

GI Stimulants


metoclopramide Metozolv®

ODT

Reglan®




Gastrointestinals: Proton Pump Inhibitors

LENGTH OF AUTHORIZATIONS: dependent on criteria met

Prilosec® OTC or Prevacid® OTC, if successful, may be continued with no limitations to duration of therapy

Protonix® (Pantoprazole) to be approved for 120 days (if 60-day trial of Prilosec® OTC or Prevacid® OTC fails)

Non-preferred products to be approved for 120 days (with failure of both Prilosec® OTC or Prevacid® OTC and

Protonix® or Pantoprazole)

For exceptions see criteria for ―Proton Pump Inhibitors exception‖

1) Step one requires a therapeutic failure of a 60-day trial of OTC Prilosec® (up to 40mg daily) or Prevacid®

OTC. For exceptions to this see criteria for ―Proton pump inhibitors exception‖.

Other things to consider when reviewing OTC Prilosec® or Prevacid® OTC

o Allergy to omeprazole or lansoprazole

o Contraindication to or drug-to-drug interaction with OTC Prilosec® (Omeprazole) or Prevacid®

OTC (lansoprazole)

o History of unacceptable/toxic side effects to OTC Prilosec® (Omeprazole) or Prevacid® OTC

(lansoprazole)

o Patient’s condition is clinically unstable; changing to OTC Prilosec® or Prevacid® OTC might

cause deterioration of the patient’s condition.

Document details

2) If has failed step one then move to step two and the other preferred medication, Protonix® (Pantoprazole)

must be tried. If there is a therapeutic failure of no less than a one-month trial with Protonix® (Pantoprazole)

then may approve the requested medication for duration of 120 days.

Other things to consider when reviewing

o Is there any reason the patient cannot be changed to Protonix®, Acceptable reasons include:

o Allergy to Protonix® (Pantoprazole)

o Contraindication to or drug-to-drug interaction with Protonix®(Pantoprazole)

o History of unacceptable/toxic side effects to Protonix® (Pantoprazole)



Document details

Gastrointestinals: Proton Pump Inhibitors exceptions

LENGTH OF AUTHORIZATIONS: If an exception is met, approve desired product and make the duration for 1

year. Step therapy requirements detailed above do not apply.

Exceptions

Erosive Esophagitis

Active GI Bleed

Zollinger-Ellison Syndrome

Greater than 65 years of age

If Failed 120 day trial and is under the care of a Gastroenterologist and has ruled out a

nonsecretory condition

Document details





Gastrointestinals: Proton Pump Inhibitors

(Continued)

Gastrointestinals: PPIs (see step edit)


pantoprazole* Aciphex® Prilosec

® Rx form

Prevacid® OTC Dexilant

® Prilosec

® Suspension

Prilosec® OTC Nexium

® Protonix

®

•omeprazole RX &OTC Zegerid®

Capsule

omeprazole/sodium

bicarbonate Zegerid®

OTC

•Prevacid®

RX Zegerid®

susp Packet

•Prevacid®

susp lansoprazole

•Prevacid®

solutab

* is subject to the step edit •no SA required if age < 12yrs

SPECIAL CONSIDERATION:

o Protonix®

is a delayed release tablet and cannot be crushed or opened.

o For tubed patients or patients with swallowing difficulties omeprazole, Prevacid®

, Prevacid Solutab®

,

Prilosec®, Nexium

® or Prevacid

® granules (if oral administration) can be used. These Proton Pump

Inhibitors may be opened and the intact granules may be mixed in apple sauce or orange juice and

administered. Alternatively, the capsules may be opened and the granules may be dissolved in a

small amount of sodium bicarbonate to form a compounded suspension for administration. The

omeprazole will be the preferred agent for these circumstances and may be approved.

o • If therapy is for a child < 12 then Prevacid®

Susp, Prevacid®

solutab, Prevacid ®

Caps or Omeprazole

will not require a SA )

o If there has been a therapeutic failure on omeprazole or there is a clinical contraindication to

omeprazole then another non-preferred agent may be approved.

o Aciphex®

is an extended release tablet and should not be opened or crushed.




Ulcerative Colitis Oral and Rectal Preparations

(5-ASA DERIVATIVES)



class?











Ulcerative Colitis – Oral


Apriso ® Asacol HD

®

Asacol ® Azulfidine Dr

®

balsalazide disodium Azulfidine IR®

Pentasa ® Azulfidine

® Susp

sulfasalazine DR Colazal®

sulfasalazine IR Dipentum

Lialda

®

Ulcerative Colitis – Rectal


Canasa® Supp. Rect Fiv-Asa

®

mesalamine enema Rowasa®

Enema

Rowasa®

Enema Kit

Rowasa®

Supp. Rect

SFRowasa®




Genitourinary

Alpha-Blockers and Androgen Hormone Inhibitors

For

Benign Prostatic Hypertrophy (BPH)



class?











Alpha-Blockers for BPH


tamsulosin HCL Flomax ®

Rapaflo®

Uroxatral®

Androgen Hormone Inhibitors for BPH


Avodart ® Jalyn

®

finasteride Proscar®




Phosphate Binders



class?








2) If there has been a therapeutic failure to at least a one-month trial of at least one medication not requiring


Electrolyte Depleters


Fosrenol® Calcium Acetate 667MG

Phoslo® Eliphos

®

Renagel® Renvela

® powder and tablet




Urinary Antispasmodics



class?






2) If there has been a therapeutic failure to at least a one-month trial of at least one medication not requiring


Urinary Antispasmodics


Detrol® LA Detrol

®

Enablex® Ditropan

®

oxybutynin Tablet Ditropan®

XL

oxybutynin Syrup Gelnique™ gel

Oxytrol® Transdermal oxybutynin ER

Sanctura® Toviaz™

Sanctura® XR

VESIcare®




Immunological agents

Self Administered Drugs for Rheumatoid Arthritis



class?














approval, then may approve the requested medication.


or a FDA-approved indication, or Age specific indication, or Medical co-morbidity, unique patient

circumstance, other medical complications, or Clinically unacceptable risk with a change in

therapy to preferred agent.

Immunomodulators – Injectable-Self Administered Drugs for Rheumatoid Arthritis

Preferred Drugs – No SA Required Non-Preferred Drugs - SA Required

Enbrel® Cimzia

®

Humira® Cimzia

® SyringeKit

Kineret®

Simponi®




Multiple Sclerosis



class?










****Clinical Edit for Ampyra

LENGTH OF AUTHORIZATION FOR AMPYRA: Initial 8 weeks then, 1 year after successful trial

Criteria:

The patient has a diagnosis of MS and a gait disorder or difficulty walking

Patient has no history of seizures

Patient’s Creatinine Clearance [CrCL] ≥ 50 mL/min.

If patient has a gait disorder, they may receive an 8 week trial of Ampyra

If after 8 week trial the physician states that the patient showed improvement or that the drug was

effective (by improved Timed 25-foot Walk), the patient may receive authorization for Ampyra for one

year.





approval, then may approve the requested medication.


or a FDA-approved indication, or Age specific indication, or Medical co-morbidity, unique patient

circumstance, other medical complications, or Clinically unacceptable risk with a change in

therapy to preferred agent.

Multiple Sclerosis Agents


Avonex® Ampyra

®****

Avonex® Adm Pack Extavia

®

Betaseron®

Copaxone®

Rebif®

****Requires a clinical SA as noted above




Atopic Dermatitis: Topical

LENGTH OF AUTHORIZATION: 1 YEAR

CLINICAL CONSIDERATIONS:


class?






2) A SA may only be given for an FDA approved Diagnosis:

o Atopic dermatitis (a type of eczema) - FDA approved:

o Elidel®: mild to moderate for ages > 2 years.

o Protopic® 0.03%: moderate to severe for ages > 2 years.

o Protopic® 0.1%: moderate to severe for ages > 18 years.

3) All other diagnoses (off-label uses) are to be referred to a clinical pharmacist. All requests for all other

diagnoses are to be denied.

Critical information for review:

o Black box warnings are in place for both products as well a requirement for a patient guide to be given

with each product dispensed.

o The FDA recommends that healthcare providers, patients and caregivers consider the following: (Updated

from FDA site 8/29/07) *•••*

o Use Elidel and Protopic only as second-line agents for short-term and intermittent treatment of atopic

dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments.

o Avoid use of Elidel and Protopic in children younger than 2 years of age. The effect of Elidel and Protopic

on the developing immune system in infants and children is not known. In clinical studies, infants and

children younger than 2 years old treated with Elidel had a higher rate of upper respiratory infections than

did those treated with placebo cream.

o Use Elidel and Protopic only for short periods of time, not continuously. The long term safety of Elidel

and Protopic are unknown.

o Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.

o Use the minimum amount of Elidel or Protopic needed to control the patient’s symptoms. In animals,

increasing the dose resulted in higher rates of cancer.

*•••*http://www.fda.gov/cder/drug/infopage/protopic/default.htm

*•••*http://www.fda.gov/cder/drug/advisory/elidel_protopic.htm

Topical Immunomodulators

Preferred Drugs - No SA Required once Clinical edit met Non-Preferred Drugs - SA Required

Elidel®**** Protopic

®****





Ophthalmic

Ophthalmic Antihistamines/Mast Cell Stabilizers




o Allergy to product formulation (i.e. dyes or fillers). If an allergy to drug class, should question

medication request.






Document details


If the patient is completing a course of therapy with a medication requiring service approval, which was initiated in

the hospital, then may approve the requested medication to complete the course of therapy.

Ophthalmic Antihistamines


Alaway OTC® Elestat

®drops Patanol

® drops

Emadine®

drop Pataday®

drops

ketotifen fumerate Zaditor®

OTC drops

Optivar ®

drops

Ophthalmic Mast Cell Stabilizers (no changes)


Alamast® drops Crolom

® drops

Alocril® drops

Alomide® drops

cromolyn sodium




Ophthalmic Anti-inflammatory





medication request.




2) If there has been a therapeutic failure to no less than a 3 day trial of one medication within the same not

requiring service approval, then may approve the requested medication. Document details.




Ophthalmic Anti-Inflammatory


ketorolac 0.4% Acular® drops

ketorolac 0.5% Acular LS® drop

diclofenac sodium drops Acular PF®

droperette

flurbiprofen sodium drops Acuvail®

drops

Nevanac® drops Susp Ocufen

® drops

Xibrom® drops Voltaren

® drops




Ophthalmic Antibiotics





medication request.





approve the requested medication.

Document details, note diagnosis and any culture and sensitivity reports



Document details




Ophthalmic Antibiotics (Fluoroquinolones & Macrolides)


ciprofloxacin drops AzaSite™ drops

ofloxacin drops Besivance®

drops

Quixin® drops Ciloxan

® drops

Vigamox® drops Ciloxan

® oint

Zymar® drops® Iquix

® drops

Ocuflox®

drops

Zymaxid®

drops




Ophthalmic- Glaucoma Agents


1) Is there any reason the patient cannot be changed to a medication not requiring service approval? Acceptable

reasons include:






o If there has been a therapeutic failure to no less than a one-month trial of at least one medication


o The requested medications corresponding generic (if a generic is available) has been attempted

and failed or is contraindicated

Glaucoma Agents Ophthalmic Prostaglandin Analogs


latanoprost Lumigan® 0.03% drops

Travatan Z® drops Xalatan

® 0.005% drops

Travatan® 0.0004% drops

Alpha 2 Adrenergic Agents


Alphagan P® 0.1% & 0.15% drops Brimonidine tartrate (0.15%)

brimonidine 0.2% drops

Iopidine® 0.5% & 1% drops

Beta Blockers


betaxolol 0.5% drops Betagan®

0.25% & 0.5% drops

Betimol® 0.25% &0.5% drops Istalol

® 0.5% drops

Betoptic-S® 0.25% susp drops Ocupress

®1% drops

carteolol 1% drops optipranolol 0.3% drops

Combigan® Timoptic

® drops 0.25% & 0.5% drops

levobunolol 0.25% & 0.5% drops Timoptic®

XE 0.25% & 0.5% Sol-Gel

metipranolol 0.3% drops

timolol maleate drops 0.25% &0.5% drops

timolol maleate 0.5 % Sol-Gel

Carbonic Anhydrase Inhibitors


Azopt® 1% drops Cosopt

® 0.5%-2% drops

dorzolamide Trusopt® 2% drops

dorzolamide/timolol




Osteoporosis Agents

Bisphosphonates and Calcitonins



class?


o Allergy to medication not requiring service approval

o Contraindication to or drug-to-drug interaction with medication not requiring service approval

o History of unacceptable/toxic side effects to medication not requiring service approval


2) Has the patient tried and failed a therapeutic trial with a preferred drug within the same class? If so, document

and approve the service authorized drug.

Bisphosphonates


alendronate Actonel®

with CA Actonel®

Fosamax® solution Boniva

® Fosamax

®

Fosamax ®plus D

Calcitonins


Miacalcin® calcitonin-salmon Nasal

Fortical®




Respiratory

Antihistamines: First and Second Generation



class?






2) If there has been a therapeutic failure after a course of treatment (e.g., one month for allergic rhinitis) with one

product not requiring service approval, then may approve the requested medication.

Document details

First Generation Antihistamines


Generic only class All Brands require an SA

Second Generation Antihistamines and Combinations


cetirizine syrup OTC/RX Allegra®

Clarinex- D®

12 hr

Claritin® OTC Allegra ODT

® Claritin-D

® - Rx forms

Claritin® OTC syrup Allegra suspension

® Claritin

® - Rx forms

Claritin® tablets- Reditabs OTC Allegra-D 12 hr

® Claritin

® Chewables

Claritin-D® 24 hr OTC Allegra-D 24 hr

® fexofenadine

Claritin-D® 12 hr OTC cetirizine chew OTC fexofenadine/PSE

loratadine tablet (represents all OTC names) cetirizine tablet OTC fexofenadine/PSE 60/120 ER

loratadine tab - Rapids (all OTC names) cetirizine D tablet OTC Xyzal®

loratadine syrup (represents all OTC names) ‡ cetirizine sol OTC Zyrtec tablet OTC/RX ®

loratadine D 24 hr (represents all OTC names) Clarinex tablet®

Zyrtec tab chew OTC/RX ®

loratadine D 12 hr (represents all OTC names) Clarinex tablet Rapids®

Zyrtec® syrup OTC

Clarinex®

syrup Zyrtec-D®

OTC/RX

Clarinex- D®

24 hr

‡ no SA required < 2yrs of age




Beta-Adrenergic Agents



class and formulation?






2) If there has been a therapeutic failure to no less than a two-week trial of at least one medication not requiring

service approval within the same class and formulation. (i.e. nebulizers for nebulizers)

Document details

ADDITIONAL INFORMATION

Patients experience cardiac and central nervous system side effects (i.e. tachycardia, agitation) more often.

Beta Adrenergic Agents


Short Acting and Combination Metered Dose Inhalers or Devices

Proair® HFA Maxair Autohaler

Proventil ®HFA Xopenex

® HFA

Ventolin® HFA Alupent

® MDI discontinued

Long Acting Metered Dose Inhalers or Nebulizers

Foradil® Brovana

®

Serevent Diskus® Perforomist

®

Short Acting Nebulizers

albuterol sulfate Accuneb®

pediatric dosing, premixed nebs

metaproterenol albuterol sulfate premix

Xopenex® Proventil

®

Levalbuterol 0.125%




COPD: Anticholinergics



class?









2) If there have been therapeutic failures to no less than one-month trials of at least two medications not requiring


Document details

COPD Anticholinergics


Atrovent HFA® Atrovent AER

®

Combivent® MDI Duoneb

®

ipratropium bromide Solution Ipratropium/Albuterol nebs

Spiriva®




Corticosteroids:

Inhaled and Nasal Steroids



class?











Document details


1) If a medication requiring service approval was initiated in the hospital, and then may approve the requested

medication.

Document details

2) If the patient is a child <13 years old or a patient with a significant disability, and unable to use an inhaler which

does not require service approval, or is non-compliant on an inhaler not requiring service approval because of

taste, dry mouth, infection; then may approve the requested medication.

Document details





Corticosteroids:

Inhaled and Nasal Steroids

(Continued page 2)

Inhaled Corticosteroids


Metered Dose Inhalers

Aerobid® Flovent Rotadisk

®

Aerobid®

M Flovent®

Asmanex® Pulmicort Flexhaler

®

Azmacort® Alvesco

®

Flovent®

HFA

Flovent® Diskus

QVAR®

Nebulizer Solution

Pulmicort® Respules budesonide

Combination Products (Glucocorticoid and Beta Adrenergic)

Advair® Diskus

Advair® HFA

Dulera®

Symbicort®

Nasal Steroids


fluticasone Allemist®

Nasonex®

Nasacort®

AQ Beconase AQ® Omnaris

®

Flonase® Rhinocort Aqua

®

flunisolide Tri-Nasal®

Nasacort®

Veramyst®

Nasarel®




Cough and Cold Agents

LENGTH OF SERVICE AUTHORIZATIONS: Date of Service


class?



Contraindication to or drug-to-drug interaction with medications not requiring service approval.

History of unacceptable/toxic side effects to medications not requiring service approval.


2. The requested medication may be approved if the following are true:

If there has been a therapeutic failure of at least one medication within the same class not requiring

service approval.


has been attempted and showed unacceptable/toxic side effects or there is an allergy, contraindication,

or drug-to-drug interaction.





Antihistamine & Decongestant COMB



Antihistamine 1st Generation & Decongestant Combination



Decongestant-Expectorant Combination



Expectorant



Narcotic Antitussive/Decongestants






Cough and Cold Agents

Continued

Narcotic Antitussive/Expectorant



Non-Narcotic Antitussive



Non-Narcotic Antitussive/Decongestants



Non-Narcotic Antitussive/1st Generation Antihistamine/Decongestants



Non-Narcotic Antitussive/Expectorant






Intranasal Antihistamines:


1) Is there any reason the patient cannot be changed to a medication not requiring service authorization within the

same class?


o Allergy to medications not requiring service authorization


authorization

o History of unacceptable/toxic side effects to medications not requiring service authorization



authorization might cause deterioration of the patient’s condition.



service authorization, then may approve the requested medication.

Document details


1) If a medication requiring service approval was initiated in the hospital, and then may approve the requested

medication.

Document details

2) If the patient is a child <13 years old or a patient with a significant disability, and unable to use an inhaler which

does not require service approval, or is non-compliant on an inhaler not requiring service approval because of

taste, dry mouth, infection; then may approve the requested medication.

Document details

Antihistamines: Intranasal


Astelin®

azelastine 0.1%

Astepro®

0.1% and 0.15%

Patanase®




Leukotriene Receptor Antagonists








2) If there has been a therapeutic failure to the agent not requiring service approval, then may approve the

requested medication.

Document details

Leukotriene Receptor Antagonists


Accolate® Zyflo CR™

Singulair®




Self Injectable Epinephrine


1) Is there any reason the patient cannot be changed to a medication not requiring service authorization within the

same class?




approval




o If there has been a therapeutic failure of no less than a one-month trial of at least one




Self Injectable Epinephrine


epinephrine Autoinjector AdrenaClick®

EpiPen® Twinject

®

EpiPen® Jr Twinject

® Jr

analgesics - virginia medicaid pharmacy services...virginia medicaid preferred drug list, effective...

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